Drug-Drug Interactions of JMKX003142 in Healthy Participants

Официальное название

A Single-center, Non-randomized, Open-label, Self-controlled, Phase I Clinical Study to Evaluate Drug-Drug Interactions (DDI) of JMKX003142 Tablets in Chinese Healthy Participants.

Обзор

This is a single-center, non-randomized, open-label, self-controlled, Phase I clinical trial to evaluate the drug-drug interactions (DDI) of JMKX003142 tablets in healthy adult participants. The study consists of five cohorts (Cohorts 1, 2, 3, 4, and 5). A total of 24 participants are planned enrollment in each of Cohorts 1, 2, 3, and 5, while 16 participants are planned for Cohort 4.

Вмешательства

• Препарат JMKX003142 tablets
  3mg once daily (QD) on Day 1 and Day 7
• Препарат Fluconazole Capsules
  400mg QD on Day 4, 200mg QD from Day 5 to Day 9
• Препарат Cocktail Substrates (Midazolam Oral Solution, Rosuvastatin Calcium Tablets, and Digoxin Tablets)
  Midazolam Oral Solution 2mg, Rosuvastatin Calcium Tablets 5mg and Digoxin Tablets 0.25mg QD on Day 1, Day 8 and Day 21
• Препарат Cyclosporine Soft Capsules
  100 mg twice daily (BID) from Day 4 to Day 9
• Препарат Omeprazole Enteric-coated Tablets
  40mg QD from Day 4 to Day 8
• Препарат Efavirenz Tablets
  600mg QD from Day 4 to Day 12
• Препарат JMKX003142 tablets
  6mg QD from Day 8 to Day 25
• Препарат JMKX003142 tablets
  6mg QD on Day 1 and Day 8
• Препарат JMKX003142 tablets
  6mg QD on Day 1 and Day 10

Первичные конечные точки

• Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites [Срок оценки: for 120 hours]
• Area Under Curve (AUC) of JMKX003142 and its metabolites [Срок оценки: for 120 hours]
• Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites [Срок оценки: for 144 hours]
• Area Under Curve (AUC) of of Midazolam and its metabolites [Срок оценки: for 144 hours]
• Maximum Plasma Concentration (Cmax) of Rosuvastatin [Срок оценки: 144 hours]
• Area Under Curve (AUC) of of Rosuvastatin [Срок оценки: for 144 hours]
• Maximum Plasma Concentration (Cmax) of Digoxin [Срок оценки: for 144 hours]
• Area Under Curve (AUC) of Digoxin [Срок оценки: for 144 hours]

Вторичные конечные точки (12)

• Tmax of JMKX003142 and its metabolites [Срок оценки: for 120 hours]
• T1/2 of JMKX003142 and its metabolites [Срок оценки: for 120 hours]
• CL of JMKX003142 and its metabolites [Срок оценки: for 120 hours]
• Tmax of Midazolam and its metabolites [Срок оценки: for 144 hours]
• T1/2 of Midazolam and its metabolites [Срок оценки: for 144 hours]
• CL of Midazolam and its metabolites [Срок оценки: for 144 hours]
• Tmax of Rosuvastatin [Срок оценки: for 144 hours]
• T1/2 of Rosuvastatin [Срок оценки: for 144 hours]
• CL of Rosuvastatin [Срок оценки: for 144 hours]
• Tmax of Digoxin [Срок оценки: for 144 hours]
• T1/2 of Digoxin [Срок оценки: for 144 hours]
• CL of Digoxin [Срок оценки: for 144 hours]

Критерии участия

Критерии включения

• Participants are able to return to the study center for follow-up as required by the protocol and are willing to comply with study policies, procedures, and restrictions; capable of effective communication with the investigator and completing study-related materials; able to understand the contents of the Informed Consent Form (ICF) and sign the written ICF prior to any study procedures.
• Healthy Chinese male or female subjects, as determined by medical history and physical examination. At the time of signing the Informed Consent Form (ICF), aged 18-45 years (inclusive) ; body weight ≥ 50 kg for males or ≥ 45 kg for females; and Body Mass Index (BMI) within the range of 19.0-26.0 kg/m² (inclusive).
• Participants were considered healthy by the Investigator based on medical history, baseline physical examination, clinical laboratory assessments, and 12-lead ECG, with all results judged as normal or not clinically significant.
• Participants of childbearing potential who agree to use effective contraception and have no plans for conception, cryopreservation, or donation of gametes from ICF signature through 3 months after the last dose.

Критерии исключения

• Known or suspected hypersensitivity to JMKX003142 (active ingredient or excipients), or a history of hypersensitivity to more than two drugs, foods, or other substances.
• History or presence of clinically significant diseases in any of the following systems (including but not limited to): cardiovascular, respiratory, gastrointestinal, hematologic, genitourinary, endocrine/metabolic, nervous, psychiatric, musculoskeletal, dermatologic, lymphatic, immune, or sensory organs; or current active local or systemic infection.
• Any condition increasing the risk of bleeding, such as acute gastritis, active ulcer with hemorrhage, clinically significant thrombocytopenia or anemia, active pathological bleeding, or a history of intracranial hemorrhage.
• Vital signs meet any of the following criteria at screening: systolic blood pressure ≥ 140 mmHg or < 90 mmHg; diastolic blood pressure ≥ 90 mmHg or < 50 mmHg; pulse rate > 100 bpm or < 50 bpm; or tympanic temperature ≥ 37.5°C or < 35°C.
• Subjects with a history of QTc interval prolongation or a family history of Long QT Syndrome; or those with clinically significant abnormal ECG findings as determined by the Investigator during screening; or a QTcF ≥ 450 ms; or a QRS interval > 120 ms.
• Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, or syphilis serology.
• Treatment with therapeutic biological products within 3 months (or 5 half-lives, whichever is longer) prior to dosing, or other prescription/non-prescription medications (including vaccines, Traditional Chinese Medicine \[TCM\], dietary supplements, and health products) within 1 month (or 5 half-lives, whichever is longer).
• Use of any investigational drug within 3 months prior to screening, or current participation in another clinical trial.
• Major surgery (e.g., requiring general or epidural anesthesia) within 3 months prior to screening, or planned surgical intervention during the study.
• History of hemophobia, belonephobia, or difficult venous access.
• Blood donation or blood loss of ≥400 mL within 3 months prior to screening.
• History of drug dependence/abuse or illicit drug use, or a positive drug screening result.
• Smoking ≥5 cigarettes per day within 3 months prior to screening, or inability to commit to abstaining from tobacco products during the study, or a positive nicotine screening result.
• History of heavy alcohol consumption (>14 units per week; 1 unit ≈ 10 mL alcohol, equivalent to approx. 285 mL beer \[3.5%\], 25 mL spirits \[40%\], or 100 mL wine \[10%\]), inability to abstain from alcohol after screening, or a positive alcohol breath test.
• Daily consumption of excessive tea, coffee, or caffeine-containing beverages (more than 8 cups per day; 1 cup = 250 mL) within 14 days prior to screening.
• Ingestion of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos) or fruit products within 3 days prior to dosing.
• Special dietary requirements, or inability to comply with a standardized diet (e.g., standard meals) and dietary restrictions.
• Pregnancy or lactation, positive pregnancy test in females, unprotected sexual intercourse with a partner within 14 days prior to screening, use of oral contraceptives within 30 days prior to screening, or use of long-acting injectable or implanted estrogens/progestogens within 6 months prior to screening.
• Requirement to drive long distances, work at heights, or operate complex machinery during the study.
• Other conditions that, in the investigator's opinion, would make the subject unsuitable for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07565441 · JMKX003142-106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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